MedPass is the leading Medical Device CRO, Regulatory and Reimbursement Consultancy in Europe specialized in medical device development and market access. Since 1991 MedPass has helped to advance the development of breakthrough medical device technologies by offering a broad range of strategic and operational services tailored to meet the needs of our clients around the globe.

We employ highly skilled professional staff who are experts in their chosen area of specialisation be it strategic consulting, clinical trial execution and biometrics to market access and reimbursement. Furthermore, we have gained experience across a broad range of therapeutic areas, medical device technologies, and all phases of medical device development from preclinical to the post marketing phase..

We are also renowned for our strong contribution to companies developing emerging technologies.

MedPass is a dynamic company, with each employee contributing to the success of device development and we are regularly recruiting enthusiastic and positive people looking to develop their skills in this exciting atmosphere.Our people need to be proactive, results-oriented and determined and proven ability will result in rapid career development

If you are interested in a career as CRA, Regulatory Affairs Consultant, Reimbursement Consultant or Junior Statistician please email your resume and covering letter to our HR Manager Julie Delrue.

Opportunities

Data manager confirme(e) (H/F)

Pour faire face à sa croissance, la CRO MedPass International, fondée en 1991, spécialisée dans la Recherche Biomédicale propose un poste de :

DATA MANAGER CONFIRME(E) (H/F)

pour renforcer son Département Biométrie (data managers, biostatisticiens). Vous participerez à toutes les étapes du Data Management depuis la mise en place de bases de données jusqu’à la validation finale des données cliniques.

En particulier, vous assurerez :

  • le développement et la mise en place de CRF (essentiellement électroniques) avec le logiciel Ennov Clinical (ClinSight),
  • la qualité des données (programmation contrôles de cohérence),
  • le suivi des essais cliniques correspondants (édition de listings, queries, tableaux de bord…),
  • la formation des équipes médicales à l’outil Ennov Clinical (ClinSight) (saisie, monitoring…).

Pour mener à bien vos missions, vous serez encadré par le Directeur du département Biométrie. Idéalement, vous êtes titulaire d’un diplôme supérieur scientifique (licence professionnelle, Master 2). Vous avez une expérience dans la Recherche Clinique entre 1 et 3 ans et maîtrisez la globalité des processus de Data Management. Vous connaissez impérativement le logiciel Ennov Clinical (ClinSight) et avez de bonnes connaissances du logiciel SAS.

Vous êtes organisé(e), rigoureux (se), avec un bon sens relationnel et vous souhaitez évoluer dans un environnement fortement international. Un bon niveau d’anglais professionnel est indispensable, autant à l’écrit qu’à l’oral.

CDI à pourvoir le plus rapidement possible.

Si ce poste, basé à Paris, vous correspond, merci d’adresser votre CV + lettre de motivation en précisant vos prétentions à l’adresse e-mail suivante: juliedelrue@medpass.org

Regulatory Affairs Project Manager – Medical Devices

MedPass International is a consulting firm specialising in the regulation and clinical development of new medical technologies. Founded in 1991 and located in Paris, MedPass International provides a full range of customised regulatory/reimbursement consulting and CRO services to medical device manufacturers seeking to place and maintain their products on the European market.

For our Department of Regulatory Affairs, we are looking for a Regulatory Affairs Associate/Consultant to work in the areas of regulatory support for clinical investigations.

Main Responsibilities:

  • to act as project manager for all regulatory aspects of a medical device clinical study, throughout the duration of the study, reporting directly to sponsors and managing internal resources.
  • to draft regulatory documentation for submission to Competent Authorities, Ethics Committees and other bodies for pre market and post market clinical investigations with medical devices.
  • to provide advice on European and national requirements and other regulatory issues relevant to clinical investigations with medical devices.

Profile:

  • Scientifically/technically qualified at least to degree level in an appropriate subject (e.g. Biomedical Engineer, Pharmacist or Scientist).
  • Ideally, at least two years post-graduate experience in the conduct, management or evaluation of clinical trials or with the development or regulation of healthcare products in the European market, of which at least one year of direct relevance to European medical device regulation.
  • Knowledge of pre- and post- market regulatory requirements and processes for medical devices in Europe.
  • Knowledge of the regulatory requirements, principles and processes applicable to clinical investigations or pre-clinical research for Medical Devices (e.g. ISO 14155, GCP, ISO 14971)
  • Expertise in a relevant specialist area relevant to medical devices would be an advantage.
  • Excellent written and verbal communication skills. Fluent English is mandatory and another European language would be desirable, particularly Italian or Spanish.
  • The ability to build and maintain excellent working relations with clients and colleagues at all levels, to take the initiative and work independently with minimal direct supervision and to organise heavy workloads effectively, successfully managing multiple tasks with competing demands, conflicting priorities and tight deadlines.

This is a permanent position, based at our head office in Paris. We may also consider applications of candidates based in UK or Germany.

Contact information:

If you are interested in this career opportunity, please send your curriculum vitae to juliedelrue@medpass.org.

Further information about MedPass International is available from our website: www.medpass.org

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